QRIOS Life Science is now looking for a Area safety specialist within the pharma industry for a consultant assignment. The ideal candidate has previous experience within the pharmaceutical industry, has strong communication skills, and has experience with IT saftey systems. About the position
The Area Safety Specialist Nordics, Local Safety will be responsible for ensuring that the Local Operating Company (LOC) Safety activities for the area (Nordics) related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any product vigilance agreements with third-party business partners. They will be responsible for having appropriate product vigilance and risk management systems in place in order to assure appropriate oversight for products within its responsibility.Responsibilities
Oversight and Providing Input
• Provide PV support to LOC for data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
• Provide support to the Hub for RRA activities, where applicable. Assure, with the Hub collaboration if applicable, that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
• Oversight of the full product portfolio, and link with local management and key stakeholders. Safety Oversight of clinical studies conducted in the territory as applicable.
• Maintaining up-to-date knowledge of local requirements for PV, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required on identification of new requirements
Submission to RA
• Coordination and submission of safety information as delegated by Marketing Authorization Holders (MAH).
• Receive and support the responses to safety-related Health Authority queries in the territory
Vigilance Service Provisions
• Ensure that day-to-day PV functions and safety activities for non-medicinal products (i.e. cosmetics, medical devices, commodities, nutritionals) are performed satisfactorily, and that regulatory compliance is maintained at Local Operating Company level
• Collaborate with the local Marketing Authorization Holders (MAH) to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA’s)) and meet their business objectives
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Maintaining local procedures where applicable and assessing the impact of the changes to the global procedure to local procedures
Agreements / Contracts containing PV Language
• Perform contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
• Coordinate the provision of support for third party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, as appropriate.
• Ensure PV inspection readiness on the LOC level at all times.
• Act as the local PV contact person for local PV audit and inspection.
• Assist inspectors / auditors; support document requests in collaboration with wider OCMS organisation.
• Address follow-up actions from findings
• Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances and develop and implement effective CAPAs
• Ensure implementation of local business continuity plans (e.g. inspection readiness, AE reporting coverage)
• Ensure an effective system is in place for 24-hour coverage.Your profile
• 4-6 years of relevant experience
• Pharmaceutical industry experience including product vigilance responsibility role is required
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field
• Proven ability to organize workflow activities and manage multiple critical issues
• Awareness and familiarity with industry principles of product vigilance, drug development, and pharmacology
• Knowledge of global, regional and local procedural documents as applicable
• Computer literate with knowledge of relevant IT safety systems.
• Excellent verbal and written communication skills
• Proven ability to negotiate and communicate with internal and external customers
• Ability to establish and maintain open relationships within the organization and with authorities
• Demonstrable knowledge of all local requirements and global aspects of product safety
• Fluency in the national language(s) and the English language is requiredAbout the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.
It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.